Cleared Traditional

OPTIMESH (K014200) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K014200 · Spineology, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2003
Decision
705d
Days
Class 2
Risk

K014200 is an FDA 510(k) clearance for the OPTIMESH. Classified as Mesh, Surgical, Metal (product code EZX), Class II - Special Controls.

Submitted by Spineology, Inc. (Stillwater, US). The FDA issued a Cleared decision on November 26, 2003 after a review of 705 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.3300 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all Spineology, Inc. devices

Submission Details

510(k) Number K014200 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received December 21, 2001
Decision Date November 26, 2003
Days to Decision 705 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
590d slower than avg
Panel avg: 115d · This submission: 705d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EZX Mesh, Surgical, Metal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3300
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.